BRAIN PORT
FDA 510(k) clearance K120691 · decided 2012-06-05
Clearance details
- K-number
- K120691
- Device name
- BRAIN PORT
- Applicant
- Nico Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-03-07
- Decision date
- 2012-06-05
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- GZT
- Device class
- 2
- Regulation number
- 882.4800
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Indianapolis, IN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 13.5 mm x 50 mm BrainPath Sheath The NICO BrainPath is a family of products that consists recall (Z-2200-2012) | Nico Corp. | 2012-08-13 |
| 13.5 mm x 60 mm BrainPath Sheath The NICO BrainPath is a family of products that consists recall (Z-2201-2012) | Nico Corp. | 2012-08-13 |